[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100345118":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":34,"responsibleParty":45,"collaborators":49,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":20,"enrollmentInfo":65,"targetDuration":20,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":77,"whyStopped":20,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ASAQ + SLD Primaquine","EXPERIMENTAL","Artesunate + amodiaquine (WHO prequalified Artesunate\u002FAmodiaquine Winthrop®) was administered orally as a fixed dose combination, at a dose of approximately artesunate 4 mg\u002Fkg + amodiaquine 10mg\u002Fkg once daily for 3 consecutive days. Primaquine was administered orally, as a single dose (0.25 mg\u002Fkg) together with the first artesunate + amodiaquine dose. All doses of medicine were administered under direct supervision. Any patient who vomited within a 30 minute observation period was re-treated with the same dose of medicine and observed for an additional 30 minutes. If the patient vomited again after the second study drug administration, he\u002Fshe was withdrawn and offered rescue therapy (Artesunate IV).",[13],"Drug: Artesunate-amodiaquine given with single low dose primaquine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Artesunate-amodiaquine given with single low dose primaquine","Three day treatment with ASAQ with SLD primaquine given with the first dose of ASAQ.",[9],null,[22,26,30],{"name":23,"affiliation":24,"role":25},"Mwinyi I Msellem","Mnazi mmoja hospital, Zanzibar Ministry of Health","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":28,"role":29},"Abduallah S Ali","Zanzibar Malaria Elimination Programme","STUDY_DIRECTOR",{"name":31,"affiliation":32,"role":33},"Andreas Martensson","Uppsala University","STUDY_CHAIR",[35],{"facility":36,"status":20,"city":37,"state":20,"zip":20,"country":38,"countryCode":20,"cosmosGeoPoint":39,"geoPoint":44,"contacts":20},"Micheweni, Bububu Jesheni, and Uzini","Zanzibar","Tanzania",{"type":40,"coordinates":41},"Point",[42,43],39.19793,-6.16394,{"lat":43,"lon":42},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"SPONSOR_INVESTIGATOR","Professor Anders Björkman","Professor",[50,53,54],{"name":51,"class":52},"Ministry of Health and Social Welfare, Zanzibar","OTHER_GOV",{"name":28,"class":52},{"name":32,"class":6},"100345118","phase-4-efficacy-and-safety-of-artesunate--amodiaquine-with-sld-of-primaquine-for-treatment-of-falciparum-malaria-in-zanzibar-100345118",false,"NCT03773536","Efficacy and Safety of Artesunate + Amodiaquine With SLD of Primaquine for Treatment of Falciparum Malaria in Zanzibar","Efficacy and Safety of Artesunate + Amodiaquine Combined With a Single Low Dose of Primaquine (0.25 mg\u002Fkg) for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Zanzibar","AcoV","Inclusion Criteria:\n\n* Age 3 months and above;\n* P. falciparum infection detected by malaria rapid diagnostic test (mRDT) and confirmed by microscopy;\n* Presence of P. falciparum malaria asexual parasitaemia (any level);\n* Presence of axillary ≥37.5 °C or history of fever during the past 48 hours\n* Ability to swallow oral medication;\n* Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and\n* Informed consent from the patient or from a parent or guardian in the case of children.\n\nExclusion Criteria:\n\n* Presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO (Appendix 1);\n* Mono-infection with a Plasmodium species other than P. falciparum detected by microscopy;\n* Presence of febrile conditions other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. severe malnutrition, cardiac, renal and hepatic diseases, HIV\u002FAIDS);\n* Regular medication, which may interfere with the study drugs;\n* History of hypersensitivity reactions or contraindications to any of the study medicines; and\n* Pregnancy","ALL","3 Months",{"count":66,"type":67},146,"ACTUAL","INTERVENTIONAL",[70],"PHASE4","The general objective of this study is to assess the therapeutic efficacy and safety of artesunate + amodiaquine combined with a single low dose of primaquine (0.25 mg\u002Fkg) for the treatment of uncomplicated P. falciparum malaria patients in Zanzibar.\n\nThe specific objectives are:\n\n* To determine the clinical and parasitological efficacy of artesunate + amodiaquine and primaquine in the treatment of uncomplicated Plasmodium falciparum infection.\n* To differentiate recurrent infections during follow-up, i.e. recrudescence from new infections, by polymerase chain reaction (PCR).\n* To evaluate the incidence of adverse events, particularly with regards to potential hematological adverse events of primaquine.\n* To determine the polymorphism of molecular markers associated with artesunate + amodiaquine tolerance\u002Fresistance.\n* To formulate recommendations, which will enable the Zanzibar Ministry of Health to make informed decisions about whether the current national antimalarial treatment guidelines should be updated or not.\n* To determine efficacy rate of the first line treatment compared to the first efficacy trial thirteen years ago.",[73],"Plasmodium Falciparum Malaria",[75,76,37],"Artesunate-amodiaquine","Single Low Dose Primaquine","COMPLETED","2018-12-10",{"date":80,"type":67},"2018-12-12",{"date":82,"type":67},"2017-05-09",{"date":84,"type":67},"2017-09-25",{"name":47,"class":6},1]